BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT TROPONIN-I

    MDR report key: 1841199 · Received September 22, 2010

    Report

    Report Number
    1415939-2010-00505
    Event Type
    Malfunction
    Date Received
    September 22, 2010
    Date of Event
    August 30, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041192
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN EVALUATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION - COMPLAINT ACTIVITY REVIEW. THE INVESTIGATION TEAM REVIEWED CUSTOMER COMPLAINTS RECEIVED TO-DATE TO DETERMINE IF OTHERS HAVE EXPERIENCED THE ISSUES ENCOUNTERED AT THE CUSTOMER FACILITY. THE REVIEW OF THIS DATA DID NOT IDENTIFY AN INCREASE IN COMPLAINT ACTIVITY FOR THE ISSUE THE CUSTOMER OBSERVED. ADDITIONALLY, THE INVESTIGATION TEAM PERFORMED A PRECISION STUDY FOR LOT 39483UN10. THE ARCHITECT STAT TROPONIN-I MEDIUM AND HIGH CONTROL LEVELS WERE TESTED SINCE THE LOW CONTROL VALUE READS BELOW 0.20 NG/ML. PER THE PACKAGE INSERT, THE ARCHITECT STAT TROPONIN-I ASSAY PRECISION IS LESS THAN OR EQUAL TO 10% TOTAL CV FOR SAMPLES LESS THAN OR EQUAL TO 0.20 NG/ML (LESS THAN OR EQUAL TO 0.20 UG/L). VALIDITY AND ACCEPTANCE CRITERIA WERE MET. THE RESULTS ARE AS FOLLOWS: MEDIUM CONTROL %CV = 5.7; HIGH CONTROL %CV = 5.0. BASED ON THE INVESTIGATION CONDUCTED, IT WAS DETERMINED THE ARCHITECT STAT TROPONIN-I LOT 39483UN10 IS PERFORMING AS INTENDED.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSE POSITIVE ARCHITECT TROPONIN-I RESULT ON AN EMERGENCY ROOM PATIENT SPECIMEN THAT REPEATED ARCHITECT TROPONIN-I NEGATIVE. THE ACCOUNT STATED THE INITIAL BLOOD DRAW WAS ARCHITECT TROPONIN-I NEGATIVE (0.00UG/L) AND THE PATIENT WAS SENT HOME PRIOR TO THE RESULTS OF THE SECOND BLOOD DRAW. THE SECOND BLOOD DRAW WAS ARCHITECT TROPONIN-I POSITIVE (0.194 UG/L, LAB CUTOFF = 0.1 UG/L) AND THE PATIENT WAS CALLED BACK TO THE FACILITY FOR ADDITIONAL BLOOD DRAWS WHICH WERE ARCHITECT TROPONIN-I NEGATIVE (0.01UG/L). THE ARCHITECT TROPONIN-I POSITIVE SPECIMEN WAS REPEATED MULTIPLE TIMES WITH NEGATIVE RESULTS. THE POSITIVE ARCHITECT TROPONIN-I RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT STAT TROPONIN-I FOR THE DETERMINATION OF CARDIAC TROPONIN-I IN HUMAN SERUM O MMI ABBOTT LABORATORIES 39483UN10

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR ARCHITECT LIST 3M74-01, SERIAL (B)(4)